Warning Letter: Lack of system control (ucm075766)

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You failed to establish and maintain process control procedures , including documented instructions and written SOPs for steps in the testing of blood and blood components [21 CFR 606.100(b), 820.70(a)(1)]. Specifically: “a) There are no written procedures describing computer software[redacted] functional requirements or descriptions of functions and there is no computer manual. The database functions as the information management tool used to collect, organize, process, analyze, secure and maintain testing data. “We also note that you have failed to establish an adequate system for authorizing, granting, and rescinding computer access to functions in the [redacted] and adequate computer security provisions to assure data integrity. Current users do not use appropriate access such as passwords and user-id and personnel who have changed jobs still have access to the system.

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Warning Letter: Inadequate validation (ucm164129)

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Failure to observe, standardize, and maintain equipment and failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements for blood and blood components [21 CFR 606.60(a)]. Specifically, the following observations were made during review of your firm’s validation of the interface between the automated blood testing instrument [redacted] and the database system, [redacted]

  • Validation sample testing and data collection was conducted on December 9, 2008, prior to approval of the validation test plan on. December 19, 2008;
  • The validation pass/fail criteria was not met;
  • The validation test plan was not followed; and
  • The validation data was incomplete.

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